Commission Implementing Decision (EU) 2024/888 of 22 March 2024 on the non-approval of certain active substances for use in biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/decision/2024/888@2024-03-22/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular Article 89(1), third subparagraph, thereof,
Whereas:
(1) Commission Delegated Regulation (EU) No 1062/2014 establishes in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products.
(2) For a number of active substance/product-type combinations included in that list, all the participants have withdrawn or are considered to have withdrawn their support in a timely manner.
(3) In accordance with Article 14(1) of Delegated Regulation (EU) No 1062/2014, the European Chemicals Agency (the Agency) published an open invitation to take over the role of participant for those active substance/product-type combinations for which the role of participant had not previously been taken over. For those combinations no notification has been submitted to the Agency within the time limit provided for by Article 14(2) of Delegated Regulation (EU) No 1062/2014. Therefore, those active substance/product-type combinations, in accordance with Article 20, first paragraph, point (b), of that Delegated Regulation, should not be approved for use in biocidal products. Those active substance/product-type combinations are the following:
(3)
(a) biphenyl-2-ol (product-type 7);
(b) potassium dimethyldithiocarbamate (product-types 9, 11, 12);
(c) silver-polyethylenimine-chloride (product-types 1, 2, 9);
(d) reaction products of glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin) (product-types 2, 4);
(e) poly(oxy-1,2-ethanediyl),.alpha.-[2-(dide-cylmethylammonio)ethyl]-.omega.-hydroxy, propanoate (salt) (Bardap 26) (product-types 2, 4, 10).
(4) In addition, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, the Agency informed the Commission of those active substance/product-type combinations for which all participants have withdrawn or are considered to have withdrawn their support in a timely manner, and for which the role of participant had previously been taken over. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (a), of that Delegated Regulation, should not be approved for use in biocidal products are the following:
(4)
(a) 2,2-Dibromo-2-cyanoacetamide (DBNPA)(product-type 2);
(b) active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis (product-type 2);
(c) garlic, ext. - Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum, Liliaceae (product-type 19);
(d) brandy (product-type 19).
(5) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The active substances listed in the Annex are not approved for the product-types indicated therein.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 22 March 2024. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX
Active substance/product-type combinations not approved: Entry Number in Annex II to Regulation (EU) No 1062/2014 Substance name Rapporteur Member State EC number CAS number Product-type(s) 92 Biphenyl-2-ol ES 201-993-5 90-43-7 7 187 Potassium dimethyldithiocarbamate SE 204-875-1 128-03-0 9, 11, 12 1076 Silver-polyethylenimine-chloride SE Not available Not available 1, 2, 9 494 2,2-Dibromo-2-cyanoacetamide (DBNPA) DK 233-539-7 10222-01-2 2 1051 Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis FR Not available Not available 2 779 Reactions products of glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin) DE 403-950-8 164907-72-6 2, 4 869 Poly(oxy-1,2-ethanediyl),.alpha.-[2-(dide-cylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26) IT Polymer 94667-33-1 2, 4, 10 1071 Garlic, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum, Liliaceae. AT 232-371-1 8008-99-9 19 1072 Brandy tbd Not available Not available 19